Chronic inflammatory diseases autoimmune and chronic inflammatory diseases castration-resistant prostate cancer
Conditions
Interventions
The planned doses are:
- Midazolam 1mg as a drink:
On day 1 once a day
On day 16 once a day
- IMU-935 150 mg as a capsule:
On days 3-15* Twice daily
On day 16 once a day
* The morning dose on Day 4
Sponsors
Immunic AG
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Sex : male or female of nonchildbearing potential 2. Age : 18 to 65 years, inclusive, at screening 3. Body mass index : 18.0 to 32.0 kg/m2, inclusive, at screening 4. Weight : >=55 kg at screening 5. Status : healthy subjects per discretion of the Investigator 6. Female subjects must be of nonchildbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year postmenopausal [amenorrhea duration of 12 consecutive months]) and have a negative serum pregnancy test at screening and a negative urine pregnancy test at each admission to the clinical research center. 7. Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner, if she is of childbearing potential) is defined as having his female partner using hormonal contraceptives or an intrauterine device combined with the use of a condom by the male subject for any sexual activity Total abstinence, in accordance with the lifestyle of the subject, is also acceptable. 8. All prescribed medication must have been stopped at least 30 days prior to first admission to the clinical research center. 9. All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John*s wort) must have been stopped at least 14 days prior to first admission to the clinical research center. An exception is made for paracetamol, which is allowed up to admission to the clinical research center. 10. Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to screening, each admission to the clinical research center, and follow-up, and during the stays in the clinical research center. Further criteria apply, see protocol.
Exclusion criteria
Exclusion criteria: 1. Previous participation in the current study. 2. Employee of PRA or the Sponsor. 3. History of relevant drug and/or food allergies. 4. Patients with a history of acute angle-closure glaucoma or untreated open-angle glaucoma. 5. Using tobacco products within 60 days prior to the first drug administration. 6. History of alcohol abuse or drug addiction (including soft drugs like cannabis products). 7. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, cotinine, and alcohol) at screening or at one of the admissions to the clinical research center. 8. Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits). 9. Estimated glomerular filtration rate calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To assess the effect of multiple doses of IMU-935 on the PK of midazolam and 1*-hydroxymidazolam after a single oral dose of midazolam when co-administered in healthy male and female subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the PK of IMU-935. - To assess safety and tolerability of a single oral dose of midazolam alone and in combination with steady-state IMU-935. - To assess safety and tolerability of multiple oral doses of IMU-935. | — |
Countries
Netherlands
Outcome results
None listed